- PTAB · Oct 6, 2026 · IPR2025-00530 · APJ Scott C Moore · IPR · Final written decision
Original claims 1–9 were canceled; the non-contingent motion to add substitute claims 10–18 was denied for lack of written-description support, and claim 18 was also indefinite.
RulingsFinal written decision- 112 supportMotion to amend, deniedDenied
“that either the ’303 application or the ’838 provisional contain adequate written description support for the disputed feature of limitation [10.d]. Though the disclosures cited by Patent Owner indicate that a secondary identifier can be used to aid in verification of a UAV, these disclosures also make clear that both first and second identifiers are transmitted by and received from the UAV. See, e.g., Ex. 2002, 4:15–17, 30:24–31:6; Ex. 2003 ¶¶ 14, 66. Patent Owner’s reliance on disclosure characterized as transmitting an identifier from a remote computing system “through the UAV” (Reply 2) is not persuasive. The cited disclosures from the ’303 application and ’838 provisional generally disclose that the identifiers transmitted by a UAV can be “generated remotely,” such as by a “remote computing system.” Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45. But Patent Owner has not identified disclosure indicating that a remote computing system may transmit an identifier to the identification receiver. In the ’303 application and ’838 provisional, only the UAV (which is part of the discrimination system, and thus not “remote”) actually transmits identifiers to the identification receiver. Patent Owner is correct in its assertion that an “aerial system identifier can be generated on-board the aerial system” or “generated remotely . . . at a remote computing system.” Mot. 7 (citing Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45). But even if a UAV’s identifier was at some time in the past generated by a remote computing system, the subsequent transmission of that identifier from the UAV to the identification receiver would not satisfy the plain language of limitation [10.d]. The claim language “receive … a second identifier from a computing system that is remote to the discrimination system” requires the receipt of a transmission of the second identifier from a remote computing system. This claim language limits the source of the received transmission (i.e., where the particular transmission is “receive[d] … from”). Thus, the relevant issue is from where was the recited second identifier received. The relevant is not where the second identifier was originally generated.” slip op. at 12
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed
“We determine that the disputed language in limitation [10.d] is not indefinite. There is no recitation in proposed substitute claim 10 that the second identifier is transmitted solely from the identifier transmission system. Thus, the alleged irreconcilable contradiction cited by Petitioner is not recited in the claims. Petitioner’s position appears to rest on the fact that the ’303 application and ’838 provisional do not disclose receiving the second identifier from a remote computing system. See Sur-reply 6 (“To manufacture written description support, [Patent Owner] argues the claim encompasses identifiers routed ‘through the UAV.’”). Though we agree that limitation [10.d] lacks adequate written description support, this defect does not render the claim indefinite because the scope of limitation [10.d] is otherwise reasonably certain based on its plain language. See supra § III.C.4.” slip op. at 18
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artPriority date, deniedDecided for patent owner
“In contrast, the ’393 provisional never discloses that the described drone defense system may use the identity of a detected drone to develop a particular countermeasure. The disclosed RTSS certainly uses identity information to determine whether a drone is a threat. And if a threat is identified, the RTSS immediately starts “a series of processes … to determine what rule of engagement will be applied on the intruding drone.” Ex. 1006 ¶ 10. The ’393 provisional discloses that the system may select a particular countermeasure based on (i) the particular zone within a protected area within which a drone is located, (ii) “the behavior of the hostile drone,” or (iii) “other instructions.” Id. ¶¶ 9, 10. But the ’393 provisional never discloses that these “other instructions” may include the identity of the drone. The system disclosed in the ’393 provisional uses the identity of a drone to determine whether to activate the countermeasure system. See id. ¶¶ 16–18. But there is no disclosure in the ’393 provisional that the countermeasure system, once activated, uses the identity of the drone to develop the particular countermeasure to be employed. See generally Ex. 1006. Thus, though the Whitmarsh reference itself contains ample written description support for limitation [19e], the earlier-filed ’393 provisional does not. On this record, and having reviewed the ’393 provisional in its entirety, we determine that the ’393 provisional does not “reasonably convey[] to those skilled in the art that the inventor had possession of” the subject matter of limitation [19e] of Whitmarsh’s claim 19 “as of the filing date” of the ’393 provisional. See Ariad, 598 F.3d at 1351.” slip op. at 27
§ 102 anticipation§ 112 disclosurecites NautilusPatents in suitUS 10,249,199 - Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentablePTAB · Oct 6, 2026 · IPR2025-00728 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–7, 9, 10, 15–18, and 20–24 are unpatentable as obvious over Schaffer with Hartley or Eller; claims 1–3, 5, 6, 9, 15–18, and 21–24 are also obvious over Hartley and Eller.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2033 ¶ 61. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:16–54 (background of the invention). Such devices include, but are not limited to, hemostasis valves and catheters for testimony of the parties’ experts, the POSA need not have had first-hand experience designing hemostasis valves. See, e.g., Ex. 1037 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required). Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Id. at 74:5–75:1. Lastly, a POSA would have understood such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience or study. Ex. 2030, 24:5–21.” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed
“above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 28
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Patent Owner cites intrinsic evidence in support of its interpretation, which include claim 1’s recitation of an “active tensioning mechanism” comprising the filament and the Specification’s description of a filament that can be both “loosened” and “tightened.” PO Resp. 14–17 (citing, e.g., Ex. 1001, 9:36–37, 9:53–56 (teaching “the filament 150 is tightened” when the actuator buttons are released and “the filament 150 is loosened” when the buttons are pressed to open the valve)); see also Ex. 2025, 1288 (defining “tension” as to “tighten to a desired or appropriate degree”). These descriptions from the patent are more consistent with the view that the filament is characteristically flexible, not rigid. 10 We reached the same conclusion, based on substantially the same records, in the Institution Decision and the Final Written Decisions in the 1157, 156, and 289 IPRs. Inst. Dec. 14–18; Ex. 1042, 14–24; Ex. 1048, 16–23; Ex. 1049, 14–17 (noting the parties’ agreement at oral hearing that there was no additional argument or evidence about whether a filament requires flexibility that was not already addressed in related matters). After we construed the “filament” term to require flexibility at institution, Petitioner provided no further argument or evidence on this issue in its authorized trial briefing or at oral hearing. See generally Pet. Reply. embodiments (where the filament forms one or more loops like depicted and described in Figures 6–7) require a flexible structure. See, e.g., Ex. 2032, 15–16 (explaining that the device would not work to constrict the tubular sidewall and lumen (analogous to the elongate member defining a lumen of the claims here) if the filament forming the loop(s) was inflexible); Ex. 1001, Figs. 6–7 (filament 150, with sub-filaments 150-A and 150-B). Although flexibility of the filament in the patent’s “bight” embodiments (e.g., as shown in Figures 8 and 9) is less clear, there is a dearth of evidence from Petitioner—either intrinsic or extrinsic to the patent—showing why a POSA would have understood the bights as embracing rigid structures. See Ex. 1001, Figs. 8–9. Moreover, as admitted by Petitioner’s expert, that a filament may be made from various materials described in the patent (e.g., synthetics or metals) does not, absent more information, lead to a conclusion that a filament is “rigid.” Ex. 2030, 125:2–126:4 (testifying “the relative stiffness or rigidity is not clear from those . . . materials without knowing much more information”).” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We find that Petitioner has not shown, by a preponderance of the evidence, that Schaffer anticipates claim 1 or any of the other challenged claims, each of which requires at least one “filament.” We are unpersuaded above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 27
Patent outcomesUS 11,844,921 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,921 - Aroma360, LLC v. Air Esscentials, Inc.All claims unpatentablePTAB · Oct 6, 2026 · IPR2025-00706 · APJ Eric C Jeschke · IPR · Final written decision
Claims 1, 4, and 7–10 are unpatentable as obvious over Goubet and anticipated by Gao; proposed substitute claims 20 and 21 are denied as indefinite and lacking written-description support.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In the Response, Patent Owner states that it “does not dispute” the definition of one of ordinary skill in the art proposed by Petitioner, but Patent Owner “reserves the right to address [the definition] should new issues materialize.” PO Resp. 6. Patent Owner did not address this issue in the Sur-reply. As noted in the Decision on Institution, Petitioner’s proposed definition appears generally consistent with the record, including the prior art. See Dec. Inst. 8 (citing In re GPAC Inc., 57 F.3d at 1579). We remove the phrase “at least” in both listed options, however, as that phrase adds ambiguity. Further, Patent Owner has not argued at trial that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would have understood either the challenged patent or the prior art. In the analysis below, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution, as proposed by Petitioner.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“Network LLC, 929 F.3d 1350, 1357 (Fed. Cir. 2019). At first glance, the language of the limitation at issue—which, again, recites “the compressed air and the operative fluid mix together in said mixing chamber to form the fluid dispersion”—would seem to require the “fluid dispersion” (under the stipulated construction) to be fully formed in the “mixing chamber.” In other words, the language of the limitation alone would seem to support Patent Owner’s proposed construction for the “form the fluid dispersion” limitation. But the claim construction analysis does not end with consideration of the claim language alone. Next, we turn to the Specification. The Federal Circuit has said that the specification “is the single best guide to the meaning of a disputed term.” Phillips, 415 F.3d at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Here, the discussion in the Specification of precisely the same language as in the limitation at issue strongly supports that “to form a fluid dispersion” in the limitation at issue requires only initial mixing of the compressed air and operative fluid in the mixing chamber, with further “formation” of the ”fluid dispersion” occurring downstream of the mixing chamber: More importantly, the “predetermined amount” of compressed air and the “preselected amount” of the operable fluid are initially mixed together in the mixing chamber 226 to form a fluid dispersion. The diffusion chamber 112" is further structured to facilitate the formation of a plurality of substantially uniform droplets, as defined hereinabove, in the fluid dispersion prior to discharge from the diffusion chamber 112" through discharge port 132. Ex. 1001, 10:62–11:2 (emphasis added) (discussing Figure 6), quoted, in part, at Pet. Reply 6–710; see also Ex. 1001, 5:64–6:4 (same language, except without double primes, in a discussion of Figures 1 and 2). To be sure, certain passages in the Specification could be read to indicate that a “fluid dispersion” must be fully formed in the “mixing chamber.” See, e.g., Ex. 1001, 6:11–12 (“More in particular, the suppression chamber 232 receives the fluid dispersion from the mixing chamber 226.”); see also id. at 7:22–33, 11:39–52 (both implying that a “fluid dispersion” is formed in the mixing chamber). But the passage block quoted directly above (and the similar one bridging columns 5 and 6) more directly addresses the issue at hand—i.e., the scope of “form the fluid dispersion”—by using the same” slip op. at 13
- Expert testimonyPatent owner expert discountedMixed
“As an initial matter, the record here does not support any sound basis to disregard the entirety of Dr. Micklow’s Declaration for allegedly not reviewing the parties’ claim constructions. See Pet. Reply 2 (citing Ex. 1046, 115:15–18). Contrary to Petitioner’s argument, in the cited discussion, Dr. Micklow does not indicate that he applied an incorrect understanding of a claim term. Cf. Cordis Corp. v. Bos. Sci. Corp., 658 F.3d 1347, 1357–58 (Fed. Cir. 2011) (disregarding testimony “based on an incorrect understanding of the claim construction”), cited at Pet. Reply 1. Instead, we read Dr. Micklow’s testimony as clarifying that he was not involved in claim construction at all and that, as stated, he “made [his] opinions based on what [he] read in the patents.” Ex. 1046, 112:11–12; see also id. at 115:15–18 (“I don’t know if I would even apply claim construction. I applied engineering principles to a document that had been published with the patent office.”).” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016); TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1066 (Fed. Cir. 2016) (“Although the KSR test is flexible, the Board ‘must still be careful not to allow hindsight reconstruction of references . . . without any explanation as to how or why the references would be combined to produce the claimed invention.’”) (citation omitted). Based on the complete record, we agree with Patent Owner that “Petitioner’s asserted motivation boils down to the conclusory statement that given Goubet and Kaiser, ‘it was well known in the field at the time of the invention that droplets of greater uniformity result in uniform droplet evaporation.’” PO Resp. 31 (quoting Pet. 59). We agree with Patent Owner that Petitioner’s discussion of the alleged reasons to combine (Pet. 59) is insufficient to support the proposed combination here. See Magnum Oil, 829 F.3d at 1380. Specifically, we are not persuaded that Kaiser’s teachings—which relate to combustion (Ex. 1014 at 43)—would have led one of ordinary skill in the art to the proposed modifications, which would allegedly “improve the smoothness (i.e., less harsh) of the aroma generated as the oil droplets evaporate in the surrounding airspace.” See Pet. 59 (emphasis added); White Pet. Decl. ¶ 251 (same); see PO Resp. 32 (“Rather, Dr. White merely describes the ability to achieve the effect as in the claimed patent, not why a [person of ordinary skill in the art] would look to the field of electrospray injection and combustion in mesoscale power-generation systems, using high-voltage electric fields to generate charged fuel droplets for controlled combustion in catalytic micro-combustors when considering atomization for scents.”). For these reasons, we determine, in light of the complete record, that Petitioner has not shown by a preponderance of the evidence that one of ordinary skill in the art at the time of the invention would have had reason to combine Goubet and Kaiser, as proposed. slip op. at 32
Patent outcomesUS 10,583,449 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 10,583,449 - Gettattle, Inc. v. Afterwords, Inc.All claims unpatentablePTAB · Oct 5, 2026 · IPR2025-00677 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–7, 10, 13, 16, 18, and 19 are unpatentable as anticipated by Douglas and Ganesh; the revised contingent motion to amend is denied.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“record before us, we conclude that Petitioner proves by a preponderance of the evidence that each challenged claim of the ’811 patent is anticipated by Douglas and by Ganesh. Accordingly, we find that claims 1–7, 10, 13, 16, 18, and 19 of the ’811 patent are unpatentable. Moreover, we find that Patent Owner’s Revised Contingent Motion to Amend adds new matter in every proposed substitute claim, and, therefore, the motion is denied.” slip op. at 80
- 112 supportMotion to amend, deniedDenied
“Because the RMTA does not meet the foundational statutory and regulatory requirements, we decline to reach Petitioner’s arguments as to the asserted unpatentability of the proposed substitute claims. C. CONCLUSION ON REVISED MOTION TO AMEND Because the RMTA does not meet foundational statutory and regulatory requirements for a motion to amend, it is denied.” slip op. at 80
Patent outcomesUS 10,430,811 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 10,430,811 - Uatp IP LLC v. Slick Slide LLCSome claims unpatentablePTAB · Oct 2, 2026 · PGR2024-00054 · APJ Brian D Range · PGR · Final written decision
Claims 22–26 are unpatentable based on obviousness; claims 1–17, 27, and 28 were not shown unpatentable. Patent Owner’s motion to terminate was denied.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“1. Mesh Layer Petitioner contends “no formal claim construction is necessary in this” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“5. Analysis On this complete record, we determine that Petitioner’s arguments do” slip op. at 31
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“form of nylon and some form of Teflon (and possible combinations thereof) having the specific coefficient of friction range given in limitation [1c] breaks down, because the building blocks of the obviousness argument are not sufficiently identified in Phillips alone, nor in the supporting testimony. Accordingly, we determine that Petitioner’s arguments and evidence fail to show that Phillips renders the challenged claims obvious. 6. Conclusion Based on the foregoing, we determine that Petitioner has not established by a preponderance of the evidence that claims 1–4, 6, and 7 would have been anticipated by or obvious in view of Phillips.” slip op. at 33
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“2. Products and Nexus We first consider the issue of whether certain evidence relied upon by” slip op. at 20
Patent outcomesUS 11,998,854 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham · NautilusPatents in suitUS 11,998,854 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Medtronic, Inc. v. Moskowitz Family LLCInstitutedPTAB · Aug 20, 2026 · IPR2026-00162 · APJ John A Squires · IPR · Director review
The Director granted the petition and instituted inter partes review of claims 8, 9, 13, and 17–21 based on Palmatier.
RulingsDirector review decision- Director reviewOther
“Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. DECISION Granting Institution of Inter Partes Review” slip op. at 1
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“1 US 9,445,919 B2, issued Sept. 20, 2016 (Ex. 1057). 2 At this preliminary stage, Petitioner establishes a reasonable likelihood that Palmatier anticipates or renders obvious the challenged claims (Pet. 22–66), and Patent Owner does not challenge Petitioner’s showings as to Palmatier.” slip op. at 2
- BurdenDecided for petitioner
“1 US 9,445,919 B2, issued Sept. 20, 2016 (Ex. 1057). 2 At this preliminary stage, Petitioner establishes a reasonable likelihood that Palmatier anticipates or renders obvious the challenged claims (Pet. 22–66), and Patent Owner does not challenge Petitioner’s showings as to Palmatier.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“Patent Owner does present some evidence of conception, diligence, and constructive reduction to practice, but Petitioner persuasively disparages that evidence on the preliminary record. For example, Patent Owner relies on April and May 2011 emails exchanged between two or more of the named inventors (Exs. 2027–2031, 2056, 2057, 2059) and a declaration from one of the named inventors, Dr. Nathan Moskowitz (Ex. 2024), to show conception of the claimed subject matter. Prelim. Resp. 8–61. Patent Owner also relies on Dr. Moskowitz’s declaration and emails (Exs. 2045, 2049, 2050) to show reasonably continuous diligence leading up to the filing of a provisional patent application. Id. at 63–66. Petitioner asserts that the documentary evidence does not show conception of the claimed “ridges,” in part, because a key email attachment regarding an embodiment for ridges has not been provided. Pet. Reply 1–4. Petitioner also asserts that Patent Owner’s relies on the declaration testimony from only one named inventor, which is vague and should be the subject of cross-examination. Id. Given these disputes, during trial, the parties are free to develop the record as to the asserted prior conception and diligent reduction to practice of the claimed subject matter, relative to Palmatier’s filing date.” slip op. at 3
§ 102 anticipationPatents in suitUS 12,011,367 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentablePTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision
The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27
Patent outcomesUS 11,896,675 not shown unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,896,675
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.